FDA Registration
Active
🇩🇪 Germany
Carl Zeiss Meditec AG (Jena)
Reg #: 9615030
·
FEI: 3001362763
·
Expires 2026
Products
22
Proprietary Names
77
Establishment Types
5
Classifications
22
Registration Details
- Registration Name
- Carl Zeiss Meditec AG (Jena)
- Registration Number
- 9615030
- FEI Number
- 3001362763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carl-Zeiss-Promenade 10
- City
- Jena Thuringia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K150467
- PMA Number
- P060004
Owner / Operator
- Firm Name
- Carl Zeiss Meditec AG (Jena)
- Operator Number
- 9053564
- Address
- Goeschwitzer Strasse 51-52
- City
- Jena
- State
- Thuringia
- Postal Code
- 07745
- Country
- DE
- Correspondent
- Carl ZEISS Meditec AG (Jena)
US Agent
- Business Name
- CARL ZEISS MEDITEC, INC.
- Contact Name
- Paul Swift
- Address
- 5300 Central Pkwy
- City
- Dublin
- State
- CA
- ZIP
- 94568
- Country
- US
- [email protected]
- Phone
- 817 9258507
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2015-06-08 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 1992-10-02 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2007-05-15 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-05-15 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2008-04-11 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2008-04-09 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2011-02-18 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2006-01-31 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2009-06-04 |
| Device, Storage, Images, Ophthalmic | NFF | Class 1 | Radiology | No | 2007-12-19 |
| Device, Communications, Images, Ophthalmic | NFG | Class 1 | Radiology | No | 2007-12-19 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2012-10-19 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2016-03-08 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2016-03-08 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2016-03-08 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2013-01-21 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2014-10-09 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2014-09-24 |
| Excimer Laser System | LZS | Class 3 | Unknown | No | 2006-11-24 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-07-18 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2014-10-09 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2007-12-05 |
Proprietary Names
Retina Workplace
VISULENS 500
VISULENS 550
Model 350, 355, 360
Humphrey Lens Analyzer Series
VisuMax (HORUS) LASER KERATOME
VISUCAM Pro NM FAF
VISUCAM 224
VISUCAM 524
VISUCAM NM/FA FAF
VISUCAM NM/FA
VISUCAM ProNM
ZEISS Slit Lamp SL 115
ZEISS Slit Lamp SL 120
ZEISS Slit Lamp HSO 10
ZEISS 20 SL Slit Lamp and Mechanical Micromanipulator
VISULAS Trion Laser System with the VITE Option
VISUREF 150
WASCA Analyzer
VISUREF 100 (URK-800)
Visulas YAG II Plus Ophthalmic Laser
Ophthalmic
ZEISS VISULAS Argon Laser
VISULAS YAG III
i.Profiler Plus
ATLAS 500
IOLMaster 500
VISUPAC 481
FF450 Plus VISUPAC System
IOL Master 700
CIRRUS photo Models 600 and 800
IOLMASTER 500
VISUCAM C Digital Camera
IOLMASTER 500 with Option Reference Image
IOLMASTER 500 with Reference Image mode
Zeiss Cataract Suite Markerless
SL 115, SL 120, SL cam 5 Digital Imaging
Power Table Model AV 100
Power Table Model AV 220
Power Table Model HFA 230
Universal instrument table IT 760
Universal instrument table IT 760W.i
Universal instrument table IT 1060.i
Universal instrument table IT 1060
Universal instrument table IT 760.i
Universal instrument table IT 760 W
Power Table Model HFA 120
Power Table Model AV 120
Power Table Model HPT 120
Power Table Model CV-120
Power Table Model AV 240
Power Table Model CV-230
Power Table Model Stratus OCT
ZEISS VISULAS YAG II Laser
VISUSCREEN 100/500
VISULAS 532s Laser System with the VITE Option
VisuScout 100
VISUPHOR 500
VISULAS Trion
MEL 80 EXCIMER LASER SYSTEM
MEL 90
Zeiss 30 SL-L
Zeiss Slit Lamp SL 130
TRENION 3D HD
MEDIALINK 100
EDIS / IDIS
VISUConnect500
VISUHEALTH
VERACITY surgical
SL Imaging Solution
SL 800
Sl 200
IOL Master
VISUPLAN 500
Indirect Ophthalmoscope
CIRRUS Photo Models 600 and 800
VISULAS 532s
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Foreign Private Label Distributor
Repack or Relabel Medical Device